Active discharge systems and methods

ABSTRACT

To avoid charge accumulation on capacitive connections to implanted electrodes during delivery of stimulation pulses, stimulation pulses are followed by active discharge pulses having opposite polarity of the stimulation pulses. The active discharge pulses preferably have at least one pulse attribute magnitude (e.g., duration, voltage, and/or current) different than a corresponding stimulation pulse and are preferably programmable. Approximately the same total net current flow is delivered during active discharge pulses as during the stimulation pulses, but in the opposite direction and optionally at a lower amplitude. In addition, by reducing the driving voltage and a variable load within the electrical path for delivery of the pulses, power dissipation during active discharge is preferably reduced.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.11/105,188, filed Apr. 12, 2005, pending, which claims the benefit ofU.S. Provisional Application No. 60/561,437, filed Apr. 12, 2004, andrelated to commonly assigned U.S. application Ser. No. 11/105,191, filedApr. 12, 2005, pending, U.S. application Ser. No. 11/105,186, filed Apr.12, 2005, pending, U.S. application Ser. No. 11/105,332, filed Apr. 12,2005, now U.S. Pat. No. 7,180,760, U.S. application Ser. No. 11/105,190,filed Apr. 12, 2005, pending, and U.S. Provisional Application No.60/648,556, filed Jan. 31, 2005, the disclosures of which areincorporated herein by reference.

TECHNICAL FIELD

The present invention is directed, in general, to pulse generation and,more specifically, to active discharge of a pulse generator.

BACKGROUND OF THE INVENTION

In delivering constant current electrical stimulation pulses by animplantable pulse generator to electrodes implanted near a stimulationsite, capacitive connections of the electrodes to a pulse generatorcircuit output driver can accumulate charge if balanced pulses are notemployed, resulting in skewing the pulses over time. Simply usingbalanced pulses, however, dissipates twice the power.

Simple passive discharge, on the other hand, requires time to dissipateaccumulated charge, potentially limiting the frequency at which pulsescan be delivered. In addition, significant charge may remain accumulatedbetween pulses, skewing the pulses over time.

BRIEF SUMMARY OF THE INVENTION

To address the above-discussed deficiencies of the prior art, it is aprimary object of an embodiment of the present invention to provide, foruse in an implantable pulse generator, active discharge pulses followingstimulation pulses and having opposite polarity of the stimulationpulses as well as programmable amplitude and duration. Approximately thesame total net current flow is delivered during active discharge pulsesas during the stimulation pulses, but in the opposite direction andoptionally at a lower amplitude. By reducing the driving voltage and avariable load within the electrical path for delivery of the pulses,power dissipation during active discharge is reduced.

The foregoing has outlined rather broadly the features and technicaladvantages of the present invention in order that the detaileddescription of the invention that follows may be better understood.Additional features and advantages of the invention will be describedhereinafter which form the subject of the claims of the invention. Itshould be appreciated by those skilled in the art that the conceptionand specific embodiment disclosed may be readily utilized as a basis formodifying or designing other structures for carrying out the samepurposes of the present invention. It should also be realized by thoseskilled in the art that such equivalent constructions do not depart fromthe spirit and scope of the invention as set forth in the appendedclaims. The novel features which are believed to be characteristic ofthe invention, both as to its organization and method of operation,together with further objects and advantages will be better understoodfrom the following description when considered in connection with theaccompanying figures. It is to be expressly understood, however, thateach of the figures is provided for the purpose of illustration anddescription only and is not intended as a definition of the limits ofthe present invention.

BRIEF DESCRIPTION OF THE DRAWING

For a more complete understanding of the present invention, reference isnow made to the following descriptions taken in conjunction with theaccompanying drawing, in which:

FIG. 1 depicts a stimulation system according to one embodiment of thepresent invention;

FIG. 2 is a high-level block diagram of a controller for an implantablepulse generator according to one embodiment of the present invention;

FIG. 3A is a block diagram for a portion of a pulse generator circuitincluding an output driver for an implantable pulse generator accordingto one embodiment of the present invention;

FIG. 3B is a simplified equivalent circuit diagram for a portion of apulse generator circuit including an output driver for an implantablepulse generator according to one embodiment of the present invention;

FIG. 4 is a timing diagram illustrating operation of a pulse generatorcircuit within an implantable pulse generator according to oneembodiment of the present invention;

FIG. 5 illustrates possible voltage accumulation at capacitiveconnections between the output switches of a pulse generator circuit andlead electrodes during stimulation pulse delivery if only passivedischarge is employed;

FIGS. 6A and 6B are a block diagram and a simplified equivalent circuitdiagram of portions of a high efficiency capacitive voltage multiplierthat may be employed for the output driver of an implantable pulsegenerator according to one embodiment of the present invention; and

FIG. 7 is a circuit diagram for a constant current voltage limited pulsegenerator circuit within an output driver for an implantable pulsegenerator according to one embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1 through 7, discussed below, and the various embodiments used todescribe the principles of the present invention in this patent documentare by way of illustration only and should not be construed in any wayto limit the scope of the invention. Those skilled in the art willunderstand that the principles of the present invention may beimplemented in any suitably arranged device.

Before undertaking the detailed description below, it may beadvantageous to set forth definitions of certain words or phrases usedthroughout this patent document: the terms “include” and “comprise,” aswell as derivatives thereof, mean inclusion without limitation; the term“or” is inclusive, meaning and/or; the phrases “associated with” and“associated therewith,” as well as derivatives thereof, may mean toinclude, be included within, interconnect with, contain, be containedwithin, connect to or with, couple to or with, be communicable with,cooperate with, interleave, juxtapose, be proximate to, be bound to orwith, have, have a property of, or the like; the terms “couple” and“connect” refer to any direct or indirect connection between two or morecomponents, unless specifically noted that a direct coupling or directconnection is present; and the term “controller” means any device,system or part thereof that controls at least one operation, whethersuch a device is implemented in hardware, firmware, software or somecombination of at least two of the same. It should be noted that thefunctionality associated with any particular controller might becentralized or distributed, whether locally or remotely. Definitions forcertain words and phrases are provided throughout this patent document,and those of ordinary skill in the art will understand that suchdefinitions apply in many, if not most, instances to prior as well asfuture uses of such defined words and phrases.

The general principles of the present invention are described withrespect to an implantable pulse generator (IPG) for generatingelectrical stimulation for application to a desired area of a body, suchas a spinal cord stimulation (SCS) system. It will be understood thatthe concepts of the present invention are not limited to an implantablepulse generator for use in an spinal cord stimulation system, but hasbroad applicability, including but not limited to different types ofimplantable devices such as spinal and neural stimulators and sensors,deep brain stimulators, cochlear stimulators, drug delivery systems,muscle tissue stimulators, and the like, including sensors and sensingsystems. Moreover, the concepts of the present invention are not limitedto use with respect to an IPG or any particular form of IPG. Forexample, embodiments of the present invention may be implemented withrespect to a fully implantable pulse generator, a radio frequency pulsegenerator, an external pulse generator, a micro-implantable pulsegenerator, etcetera.

FIG. 1 depicts a stimulation system according to one embodiment of thepresent invention. The stimulation system 100 generates and applies astimulus to a tissue or to a certain location of a body. In generalterms, the system 100 includes an implantable pulse generator (IPG) 101providing a stimulation or energy source and a lead 102 for applicationof the stimulus pulse(s).

Lead 102 includes a lead body 103 extending between a distal end 104 anda proximal end 105. Lead body 103 contains internal conductors, eight inthe exemplary embodiment shown, extending a substantial distance of thelength of lead 102 from the proximal end 105 towards the distal end 104,with the leads having lead connectors (not shown) at the proximal end105 and terminating at exposed contact or ring stimulation electrodes106-113 near the distal end 104. The conductors provide electricalconnection from individual lead connectors to each of a correspondingone of electrodes 106-113. In the exemplary embodiment, the lead 102 isgenerally configured to transmit one or more electrical signals fromimplantable pulse generator 101 for application at, or proximate to, aspinal nerve or peripheral nerve, or other tissue via stimulationelectrodes 106-113.

As will be appreciated, the connectors for electrodes 106-113 aresituated within a receptacle of the implantable pulse generator 101 andare therefore not visible in FIG. 1. The connectors electrically connectelectrodes 106-113 in lead 102 to individual outputs of a pulsegenerator circuit within the implantable pulse generator 101. Theimplantable pulse generator 101 generates and sends electrical signalsvia the lead 102 to the electrodes 106-113. The electrodes 106-113 arepositioned at or proximate to one or more stimulation sites (not shown)within the body that is to receive electrical stimulation. Eachstimulation site may be, for example, adjacent to one or more nerves inthe central nervous system (e.g., spinal cord). The implantable pulsegenerator 101 is capable of controlling the electrical signals byvarying signal parameters such as intensity, duration and/or frequencyin response to control signals provided to the implantable pulsegenerator 101.

As will be appreciated, any number of conductors and correspondingstimulation electrodes may be utilized within lead 102, and lead 102 isshown with eight conductors/electrodes for purposes of illustrationonly. In addition, other types, configurations and shapes of stimulationelectrodes (and lead connectors) known to those skilled in the art maybe used. An optional lumen (not shown) may extend through the lead 102and may be used for different purposes, including the delivery ofchemicals or drugs.

Lead body 103 is a structure typically having a round cross-section, asin the exemplary embodiment, although the cross-section of the lead body103 may be configured in any number of cross-sectional shapesappropriate for the specific application. Lead body 103 generallyincludes a lead body insulator configured to surround and insulate theconductors and present a biocompatible external surface to the bodytissue, while leaving stimulation electrodes 106-113 exposed.

As shown in FIG. 1, the lead 102 in stimulation system 100 is coupled tothe stimulation implantable pulse generator 101. In the exemplaryembodiment, the implantable pulse generator 101 is either aself-contained implantable pulse generator (SCIPG) having an implantedpower source such as a long-lasting or rechargeable battery or anexternally-powered implantable pulse generator (EPIPG) receiving atleast some of the required operating power from an external powertransmitter, preferably in the form of a wireless signal, which may beradio frequency (RF), inductive, etc. As is known in the art, theimplantable pulse generator 101 is capable of being implanted within thebody (not shown) selected to receive electrical stimulation from theimplantable pulse generator 101.

Stimulation system 100 also optionally includes an externalprogrammer/controller 114 to program and/or control the implantablepulse generator 101 via a wireless communications link 115 between theimplantable pulse generator 101 and the external programmer/controller114. Implantable pulse generator 101 preferably includes an RF receiver(or transceiver) operative for wireless communications with an RFtransmitter (or transceiver) 116 within programmer/controller 114. Acontroller 117 within programmer/controller 114 operates to controlimplantable pulse generator 101 via the wireless communications signalsas described in further detail below.

When implantable pulse generator 101 is self-contained, theprogrammer/controller 114 may also provide power to the implantablepulse generator 101. Optionally, however, a separate power controllermay be provided for charging the power source within implantable pulsegenerator 101. In some commercial embodiments, programmer/controller 114is referred to as an external patient controller/programmer (EPP).

As shown in FIG. 1, lead 102 is coupled to implantable pulse generator101, and is implanted together with the implantable pulse generator 101with the electrodes 106-113 disposed proximate to the locations within abody that are to receive electrical stimulation. Implantable pulsegenerator 101 in turn receives communication/power signals at the RFreceiver/transceiver therein via the wireless link 115 fromprogrammer/controller 114 located outside the body to receive electricalstimulation.

Accordingly, a user of the stimulation system 100 may use theprogrammer/controller 114 to provide control signals for the operationof the implantable pulse generator 101 by operation of user controls(not shown) on programmer/controller 114 and functioning as inputs tocontroller 117. The controller 117 provides control signals to thetransmitter 116, which transmits corresponding signals (and optionallypower) to the receiver within the implantable pulse generator 101, whichresponsively varies the parameters of electrical signals transmittedthrough electrodes 106-113 to the stimulation site(s).

FIG. 2 is a high-level block diagram of a pulse generator controllerwithin an implantable pulse generator according to one embodiment of thepresent invention. Pulse generator controller 200 is implemented bycircuitry and/or software disposed within implantable pulse generator101. In the exemplary embodiment, controller 200 includes a voltageregulator 201 and a reed switch 202 connected to an RF reset module 203,which is coupled in turn to a microprocessor (or microcontroller) 204.An RF receiver 205 is also connected to microprocessor 204, which isconnected to the pulse generator circuit universal custom output driver(UCOD) 206. Universal custom output driver 206, preferably implementedas a single integrated circuit, is connected, in turn, to electrodeconnectors 207 receiving the connectors for lead 102.

FIG. 3A is a block diagram for a portion of a pulse generator circuitincluding an output driver for an implantable pulse generator accordingto one embodiment of the present invention. Universal custom outputdriver 206 of the embodiment illustrated in FIG. 3A includes a currentcontrol mechanism 300 setting the current driven through the electrodesduring delivery of an electrical stimulation pulse. A digital-to-analogconverter (DAC) 301 and a scale circuit 302 current value set by currentcontrol 300 based on an eight-bit input signal and a four-bit inputsignal, respectively. In the exemplary embodiment, scale circuit 302includes or is connected to a current source or sink.

Current control mechanism 300 is also connected via a high-voltageprotection circuit 303 and the electrodes at which the electricalstimulation pulse is to be delivered to another current source or sink(that is, if scale circuit 302 includes or is connected to a currentsink, the electrodes are connected to a current source and vice versa).In this manner, current control 300 forms part of a current pathincluding the electrodes and the patient's body. A shunt circuit 304 isused to selectively direct current around the electrodes and patient toan alternate current sink or source, within or connected to shuntcircuit 304, under control of a single input bit.

FIG. 3B is a simplified equivalent circuit diagram for a portion of apulse generator circuit including an output driver for an implantablepulse generator according to one embodiment of the present invention. Inthe equivalent circuit, the current control circuit 300 within universalcustom output driver 206 includes an operational amplifier (op-amp) 305.The output of the operational amplifier 305 is connected to the gate ofa field effect transistor (FET) 306. One terminal of transistor 306 isconnected to a terminal of a high voltage protection source-followerconfigured transistor 303 and, through a shunt resistor 307 and a shuntswitch 308 forming the shunt circuit 304, to the battery voltageV_(BATT).

The other terminal of transistor 303 is connected to the AMPOUT signal,which in turn is coupled to the VCATHODE signal. The VCATHODE signal isconnected by one of switches 309 to an electrode or optionally by switch310 to a VANODE signal, corresponding to the voltage driven on theselected anode electrode. The VANODE signal is connected by one ofprogrammable switches 309 to an electrode, and selectively to one of (a)the V_(BATT) voltage, available on an output of the voltage multiplier311, (b) the V_(MULT) voltage generated by voltage multiplier 311 or (c)the 2V_(BATT) voltage generated by voltage multiplier 311.

The other terminal of transistor 306 (the one not connected totransistor 303) is connected to the SCALE input signal, to one input ofoperational amplifier 305, and to one terminal of scale circuit 302.Scale circuit 302 may be implemented, for example, by adigitally-controlled resistance that may be selectively varied. Thevariable output of scale circuit 302 is also connected to the same inputof operational amplifier 305 as the terminal of transistor 306 and theSCALE input signal. The other terminal of scale circuit 302 is coupledto ground.

The variable output terminal of digital-to-analog converter 301 isconnected to the other input of operational amplifier 305. The otherterminal of digital-to-analog converter 301 is connected to a currentmirror (not shown) transmitting a bias current I_(BIAS) of approximately800 nA through the digital-to-analog converter 301 to ground. Theimplementation of digital-to-analog converter 301 is preferably selectedfor monotonicity of the output function (e.g., a ladder resistor).

Current control 300 sets the amplitude of output current I_(OUT) drivenfor the electrical stimulation pulse. Each of the outputs 312 forprogrammable switches 309 is connected through a capacitor (not shown)to one of the electrodes 106-113. Switches 309 programmably connect,with timing controlled by input signals PULSE and INVERTCLK, one or moreof the electrodes 106-113 to the anode voltage VANODE and one or more ofthe electrodes 106-113 to the cathode voltage VCATHODE to deliver theelectrical stimulation pulse to the desired location(s). In addition,each of outputs 312 may be selectively tri-stated (set to ahigh-impedance state), so that each electrode 106-113 may be connectedas an anode, connected as a cathode, or tri-stated (off).

During operation, the universal custom output driver 206 storesswitching patterns for controlling connection of switch outputs 312within a memory (not shown). The switching patterns define parametersfor electrical stimulation pulses, including the lead electrode 106-113to be employed as anode and as cathode. For delivery of an electricalstimulation pulse according to embodiments of the invention, switches309 connect at least one of the outputs 312 to the selected anodevoltage VANODE, and at least one other of the outputs 312 to a cathodevoltage VCATHODE (which is also the output voltage AMPOUT that may beemployed for selective monitoring of any output pulse delivered). Inthis manner, an electrical pulse is selectively transmitted throughselected one(s) of the electrodes 106-113 and returned through otherselected one(s) of the electrodes 106-113 for delivery of thatelectrical pulse to the desired stimulation site(s) according to anembodiment.

The functionality of universal custom output driver 206 also includesinversion of the switching pattern(s) retrieved from the memory so thatthe previously selected anode electrode(s) becomes the cathodeelectrode(s) and the previously selected cathode electrode(s) becomesthe anode electrode(s) (and all other electrodes remain unused). Thisfunctionality is employed for active discharge, as described in furtherdetail below.

The universal custom output driver 206 also controls anode sourcevoltage selection, selecting the anode voltage VANODE from one of twicea battery voltage 2V_(BATT), a voltage multiplier output voltageV_(MULT), and the battery voltage V_(BATT), all generated by capacitivevoltage multiplier (VMult) 311 as described in further detail below.

Switches 309 are also employed to provide transition blanking,controlled one clock cycle blanking of the anode electrodes within thelead 102 upon a signal change for patient safety. Such blanking may beaccomplished by selectively tri-stating the outputs 312 to provideblanking without altering the stored memory or register switchingpatterns. During delivery of an electrical stimulation pulse, switch310, controlled by an input signal DISCHARGE, is normally open. Betweenpulses, switch 310 is closed to allow passive discharge of thecapacitive connections between outputs 312 and corresponding electrodes106-113.

FIG. 4 is a timing diagram illustrating operation of a pulse generatorcircuit within an implantable pulse generator according to oneembodiment of the present invention. The traces depicted illustrate,respectively from top to bottom, the PULSE signal, the INVERTCLK signal,the voltage at the variable output terminal of the digital-to-analogconverter 301, the electrical stimulation constant current pulse I_(OUT)delivered through the anode electrode, and the resistance at thevariable output terminal of the scale circuit 302.

Amplifier Pre-Charge

In implementing universal custom output driver 206 according toembodiments of the present invention, power consumption is balancedagainst slew rate. Operational amplifiers having a slew rate acceptablefor high frequency operation (i.e., short electrical stimulation pulseduration) typically have high power consumption, an importantconsideration for battery life and/or the interval between requiredrecharging cycles. Low power amplifiers, on the other hand, have a poorslew rate that can constrain the frequency or duration of electricalstimulation pulses, or simply provide poor stimulation performance.

The electrical stimulation pulse delivered to the patient through theanode and cathode electrodes is a programmable constant current pulseproduced by forcing a known voltage across a very low sampling resistorthat is electrically connected in series with the patient via sourcefollower 303 through the selected cathode. Embodiments of the presentinvention enables use of a low power (and lower cost) implementation foramplifier used in delivering that pulse by providing a pre-charge periodfor each pulse. As illustrated in FIG. 4, the voltage at the variableoutput terminal of the digital-to-analog converter 301 is increased onthe leading edge of the PULSE and INVERTCLK signals. This results in theoutput of operational amplifier 305 increasing to a predeterminedvoltage, preferably a voltage slightly above the voltage at which sourcefollower transistor 306 begins conducting.

By pre-charging the internal electronics of the operational amplifier305, which are biased using low internal voltages, and the output ofoperational amplifier 305 to an output voltage close to the thresholdvoltage at which transistor 306 begins conducting, the time required forthe amplifier output voltage to be raised above that threshold voltage,turning transistor 306 on and initiating delivery of an electricalstimulation pulse through the anode and cathode electrodes, is reduced.Transistor 306 has a large width-to-length ratio to minimize resistance,which results in a high gate capacitance that can degrade slew rate. Theconstant current pulses delivered for electrical stimulation thereforehave very fast rise times (slew rate).

To provide fast rise and fall times at low power consumption, anamplifier pre-charge period preceding the output pulse is employed,during which the amplifier is powered up but drives a low output current(about 100 microamperes) through the transistor 306 (by setting thescale circuit 302 to a high resistance value). Use of such a pre-chargeperiod is facilitated according to embodiments since (a) a shunt path isprovided, and (b) the amplifier output needs only to be operable forshort, predictable periods of time, and may in fact be powered down(e.g., not a sleep mode) between pulses to reduce power consumption. Theoutput current produced by pre-charging is shunted around the patient,with switch 308 closed by the SHUNT signal so that the delivered currentpasses through resistor 307. The output pulse to the patient startsimmediately following the amplifier pre-charge period since theamplifier is already near the operating point (a change of onlymillivolts rather than volts is required).

The net pulse width of the output pulse delivered to the patient is theduration between the leading edge of the PULSE signal and the trailingedge of the INVERTCLK signal minus the amplifier pre-charge period. Inthe exemplary embodiment, the amplifier pre-charge period isprogrammable from 1-3 clock cycles in half-cycle steps. The reduction ofthe output pulse duration by the amplifier pre-charge period isautomatic within universal custom output driver 206 of the illustratedembodiment, significantly reducing the burden on microcontroller ormicroprocessor 204.

In the illustrated embodiment of the present invention, transistor 306at the output of operational amplifier 305, within the current sinkpath, is a field effect transistor (FET) rather than a bipolar junctiontransistor (BJT). This contributes to providing fast rise timesfollowing pre-charging, since a faster switching speed may be obtained.

To minimize wasted power during pre-charging, the resistance of scalecircuit 302 is preferably set to the largest resistance value tolerablewhile still achieving acceptable rise time.

Constant Current Pulse with Scaling

The amplitude of the constant current output I_(OUT) of the illustratedembodiment is controlled by the combination of digital-to-analogconverter 301 and scale circuit 302. To deliver the electricalstimulation pulse at the end of the amplifier pre-charge periodaccording to embodiments of the invention, the resistance of scalecircuit 302 is reduced to a value corresponding to the selected, desiredoutput current range, and switch 308 is concurrently opened. Thedigital-to-analog converter 301 of embodiments controls the preciseoutput current within the selected range for the electrical stimulationpulse that is delivered. At the end of the output pulse, the amplifieris clamped and the resistance of scale circuit 302 is again raised to ahigher value.

Rather than employing a fixed resistor within the current sink path andvarying the voltage input to operational amplifier 305, or alternativelyfixing the voltage input to the operational amplifier 305 and employinga variable resistance in the current sink path, embodiments of thepresent invention provide both a digitally-controlled variable voltageinput to operational amplifier 305 and a variable resistance within thecurrent sink path to control the output current for an electricalstimulation pulse. Such use of dual variable controls over the currentamplitude is facilitated at least in part because digital-to-analogconverter 301 is monotonic, as described above.

Use of dual variable controls allows the scale circuit 302 to beemployed to set a range for the output current I_(OUT), or as a coarseresolution control. Strictly by way of example, scale circuit 302 may beemployed to select between one of the following ranges: 0-25.6milliamperes (mA), 0-12.8 mA, 0-6.4 mA or 0-1.6 mA.

Digital-to-analog converter 301 is then employed to select a particular(stepped) output current I_(OUT) within the selected range, or as a fineresolution control. In the exemplary embodiment, the resolution dependson the number of step increments provided by digital-to-analog converter301 and the range selected by scale circuit 302. That is, scale circuit302 of embodiments provides ratiometric output current accuracy throughresistance adjustment while digital-to-analog converter 301 providesmonotonic output current accuracy through voltage adjustment. Forinstance, using the above-described exemplary ranges, adigital-to-analog converter 301 capable of operation in 256 incrementswould have a resolution of 100 microamperes (IA) for the largest rangeof 0-25.6 mA, a resolution of 50 μA for the second-largest range of0-12.8 mA, a resolution of 25 μA for the next-to-smallest range of 0-6.4mA, and a resolution of 6.25 μA for the smallest range of 0-1.6 mA.

In operation according to embodiments of the invention, scale circuit302 is programmably controlled to automatically select the smallestrange permitting delivery of the target output current amplitude. Forexample, if an output current amplitude of 6.2 mA is desired for anelectrical stimulation pulse, scale circuit 302 of an embodiment willautomatically be set for the above-described exemplary range of 0-6.4mA, rather than the higher ranges of 0-12.8 mA or 0-25.6 mA. Selectionof the smallest range including the desired stimulation pulse amplitudeboth reduces power dissipation by the output driver to conserve powerand allows maximum (fine) stimulation pulse amplitude adjustmentresolution to be used in any adjustment by the patient.

A benefit of the coarse and fine resolution approach described above isthat the finer resolution inherently achieved at lower output currentranges is better suited for patient adjustment. If a large amplitudecurrent pulse is required for stimulation (say, 20 mA), coarseadjustment (e.g., in increments of 100 μA) will be acceptable to thepatient, who might not perceive any difference if finer resolutionadjustment (e.g., in increments of 6.25 μA) were provided at that outputcurrent pulse amplitude level.

In embodiments of the present invention, scale circuit 302 serves threefunctions: selection of the output current I_(OUT) or range duringdelivery of the electrical stimulation pulse; scaling of the outputcurrent I_(OUT) by 1:1, 1:2 or 1:4 during the active discharge(described below); and scaling of the output current I_(OUT) to a lowlevel during the amplifier pre-charge period, as described above. Fromthe above, it should be appreciated that the use of digital-to-analogconverter 301 and scale circuit 302 of embodiments of the presentinvention provides control with respect to the output pulse current forproviding scaling (e.g., magnitude selection), ramping (e.g., selectionof incrementally larger or smaller magnitudes within a series ofpulses), stimulation pulse/active discharge pulse ratio selection (e.g.,1:1, 1:2, or 1:4 ratio selection), and pulse wave shaping (e.g.,selection of different magnitudes within a pulse to provide a steppedpulse etcetera).

In addition to contributing to providing fast rise times throughpre-charging, the use of field effect transistor 306, digital-to-analogconverter 301 and scale circuit 302 in combination with operationalamplifier 305 in the present invention improves relative accuracy(versus less-important absolute accuracy) during scaling of the outputpulse current. Use of field effect transistor 306 also facilitatesdirect error measurement based on the gate voltage, and results in lessoverhead voltage being “thrown away.” Use of digital-to-analog converter301 and scale circuit 302 further facilitates scaling for activedischarge, described below.

Patient Shunt

In addition to enabling pre-charging of operational amplifier 305, theshunt path provided by resistance 307 and switch 308, under the controlof SHUNT signal, improves reliability of operation and patient safety bypreventing delivery of leakage current to the stimulation site betweenpulses. Optionally an overvoltage or other exceptional condition mayalso close switch 308 to make the shunt path available in lieu ofdriving current through the patient.

Switch 310, around switches 309 and electrode outputs 312, couldoptionally be switched in conjunction with switch 308, providing alow-resistance path around the lead 102 to minimize any current flowingthrough the electrodes should a current pulse be inadvertentlydelivered.

Active Discharge Control

As previously described, the electrodes 106-113 within lead 102 areconnected to switches 309 by capacitors (not shown). Because fieldeffect transistor 306 is employed within the current sink path of theillustrated embodiment rather than a bipolar junction transistor (forwhich a base current is required in order to have collector current),simply removing power does not ensure that passive discharge (capacitivebleed-off) does not include delivery of an inadvertent and potentiallystimulating current to the electrodes. In addition, where high pulserates are used—e.g., occurring at frequencies above approximately 250Hertz (Hz)—passive discharge may not fully discharge the capacitors andmay result in charge accumulation, as illustrated in FIG. 5.

In embodiments of the present invention, following delivery of anelectrical stimulation current pulse, a signal having the oppositepolarity is driven to discharge the capacitors, as depicted in FIG. 4.After a one clock cycle blanking period following the trailing edge ofthe INVERTCLK signal, in the illustrated embodiment, a non-stimulatingcurrent (stimulation is direction-specific) is driven in the oppositedirection through the electrodes used to delivery the stimulation pulse.During delivery of that non-stimulating pulse, switches 309 reverse theanode and cathode electrodes that were employed to deliver thestimulation pulse. That is, if electrode 112 was the anode and electrode111 was the cathode for the stimulation pulse, electrode 111 will be theanode and electrode 112 will be the cathode for the subsequent activedischarge pulse.

In addition, despite the direction-specific nature of stimulationpulses, inadvertent stimulation may be further avoided by driving the(negative) active discharge pulse with 1/nth of the magnitude and ntimes the duration of the stimulation pulse. That is, the activedischarge pulse may have one-fourth the current amplitude of theelectrical stimulation pulse just delivered, but four times theduration, resulting in substantially the same net charge or currentflow. The capacitive connections between the pulse generator circuit andthe electrodes may thus be substantially fully discharged (althoughnominal remaining charge or reverse charge is acceptable, and may bedepleted by passive discharge between pulses). The scale circuit 302provides the necessary scaling of the current magnitude, while activedischarge timing control to the operational amplifier 305 providescaling of the active discharge pulse width (duration). In the presentinvention, the current and pulse width scaling is programmable to 1:1,2:1 or 4:1 (i.e., n=1, n=2 or n=4).

By delivering consecutive pulses of opposite polarity but equal charge,the net charge remaining on the output capacitors connecting switches309 to electrodes 106-113 is reduced to near zero. Passive discharge,facilitated by switch 310, should easily dissipate any remaining chargeaccumulation before the next stimulation pulse is initiated.

Those skilled in the art will note that active discharge could as muchas double (200%) the power consumed during delivery of stimulationpulses, shortening the battery life or recharge cycle interval. In thepresent invention, however, both the anode voltage and the pulse currentcan be controlled simultaneously (or individually), with the pulsecurrent controlled by the variable output of digital-to-analog converter301, the variable resistance of scale circuit 302, or a combination ofthe two. Simultaneous selection of (a) a different anode source voltagethan used for delivery of the stimulation pulse, and (b) a lowervariable output value of scale circuit 302 may reduce overall powerconsumption for active discharge, taken together with stimulation, from200% to 125%. That is, the same current is driven between theelectrodes, but at less power since the resistance (provided by scalecircuit 302) within the sink path is reduced. Alternatively, powerconsumption may be somewhat reduced by adjustment of only one of theanode source voltage and the variable output of digital-to-analogconverter 301 alone, with a corresponding adjustment of the variableoutput for scale circuit 302. In either case, however, active dischargeis asymmetrical and current amplitude, without variation of the drivingvoltage and the sink path resistance.

Since the combined stimulation and active discharge pulses have a totalduration of up to five times the desired stimulation pulse width, amalfunction resulting in the stimulation and active discharge pulsesbeing delivered in the same direction (rather than opposite directions)at the stimulation site could present a hazard to the patient. For thisreason, output switches 309 are preferably monitored to confirm polaritychange and mitigate the potential hazard.

High Efficiency Capacitive Voltage Multiplier

Voltage multiplier 311 depicted in FIG. 3B receives as an input at leastthe battery voltage signal V_(BATT), and produces and outputs a set ofvoltages selected from ½V_(BATT), V_(BATT), 1½V_(BATT), 2V_(BATT),2½V_(BATT), 3V_(BATT) and 4V_(BATT), or alternatively has the outputsshut off. Accordingly, voltage multiplier 311 of the illustratedembodiment provides a fractional voltage converter. The particular setof voltages from those listed that are produced and output by voltagemultiplier 311 is programmably controlled, but always includes V_(BATT)and 2V_(BATT) in the exemplary embodiment. Moreover, the particularvoltages provided by a voltage multiplier implemented according toembodiments of the present invention are not limited to those set forthabove. For example, voltage multiplier 311 may receive as an input atleast the battery voltage signal V_(BATT), and produces and outputs aset of voltages selected from ¼ V_(BATT), ½ V_(BATT), ¾ V_(BATT),V_(BATT), 1¼ V_(BATT) , 1½ V _(BATT), 1¾ V_(BATT), 2 V_(BATT), 2¼V_(BATT), 2½ V_(BATT) , 2¾ V _(BATT), 3 V_(BATT) , 3¼ V _(BATT), 3½V_(BATT), and 3¾ V_(BATT), or off.

FIGS. 6A and 6B are a block diagram and a simplified equivalent circuitdiagram of portions of a high efficiency capacitive fractional voltagemultiplier that may be employed for the output driver of an implantablepulse generator according to one embodiment of the present invention. Asdepicted in FIG. 6A, voltage multiplier 311 includes a clock levelshifter 600, medium voltage (up) level shifter(s) 601, high voltage (up)level shifters 602, a transmission gate network 603, clock down voltagelevel shifter/delay units 604 and 605, low, medium and high voltagelevel switching field effect transistors 606, 607 and 608, and amultiplexer 609.

To provide the different anode voltages (e.g., ½V_(BATT), V_(BATT), 1½V_(BATT), 2V_(BATT), 2½V_(BATT), 3V_(BATT) and/or 4V_(BATT)) employedfor both precise current magnitude control and reduced power activedischarge, a switch capacitive voltage multiplier 311 is implemented bya charge multiplier (charge pump) using level shifters and field effecttransistors driven by a non-overlapping clock. Conventional techniquesfor implementing a charge multiplier using level shifters may beemployed, using an array of selectable low impedance switches to chargeand discharge a set of pump capacitors into larger output capacitors toproduce the desired output voltage from the voltage multiplier (VMult)311.

For reliability, high-voltage field effect transistors are generallypreferred, for example, for output switching (or in level shifting orconnection by the transmission gate network in the implementation of thepresent invention) of the higher voltages produced by the voltagemultiplier. Such high-voltage field effect transistors consume a muchlarger area (three to five times as much) than low-voltage field effecttransistors having similar conductivity, and are substantially lesspower efficient.

In addition, capacitive multipliers exhibit acceptable efficiency ingenerating exact multiples of an input voltage, but poor efficiency inbetween such voltage points. It would be useful to provide fractionalmultiples of the input voltage at an output (i.e., ½V_(BATT),1½V_(BATT), and/or 2½V_(BATT)).

Accordingly, in embodiments of the present invention, a combination ofhigh-voltage, medium-voltage, and low-voltage field effect transistors606-608 are employed in different portions of the voltage multiplier 311depending on the voltage level produced. High-voltage field effecttransistors are employed for level shifting, in the transmission gatenetwork, and for output switching of, for example, 4V_(BATT) voltages.Medium-voltage field effect transistors are employed for level shifting,in the transmission gate network, and for output switching of 2V_(BATT)voltages. Low-voltage field effect transistors are employed in thetransmission gate network and for output switching of V_(BATT) voltages.

For the higher output voltages (e.g., 3V_(BATT) or 4V_(BATT)), theoutput switches 607-608 of the illustrated embodiment are clocked by ahigher voltage signal consistent with the output voltage being switched.Accordingly, the received clock signal is level shifted up to theappropriate voltage level (e.g., from 2.2 V up to 14 V). Use of threeseparate level shifters would unduly complicate clock synchronization.Accordingly, in embodiments of the present invention, all clocks insteadare synchronized through a single up level shifter 600, which shifts theclock signal up to the maximum voltage level. The clock signal is thenlevel shifted back down as needed in level shifters/delay units 604-605.Since high-voltage field effect transistors require longer switchingspeeds, use of high-voltage field effect transistors to level shift upto the highest voltage (and partially back down, as appropriate), andmedium-voltage and low-voltage field effect transistors in levelshifting back down to the medium and low voltages, reduces thecomplexity of synchronization, requiring that less delay be introducedin level shifters/delay units 604-605.

The clock signals are passed through the transmission gate network, butpreferably only to those switching devices 607-608 necessary to outputthe appropriate voltage transmitted by level shifters 601-602. Thetransmission gates within network 603 are preferably pull-up and/orpull-down transmission gates, such that when a transmission gate is off,the corresponding switching device within field effect transistors607-608 is also off. Since source-drain connections are used to passvoltages through the transmission gate network 603, (gate) capacitanceeffects are reduced, lowering the power consumed by voltage multiplier311.

The minimum number of high-voltage field effect transistors possible arepreferably employed to level shift up to the maximum voltage.Medium-voltage and low-voltage field effect transistors are then used totruncate down to other desired output voltages (less than the maximum).Power consumption from charging and discharging the gates of themedium-voltage and low-voltage field effect transistors is therebyreduced, since level shifting down requires less through-current thanlevel shifting up. In addition, this configuration of high-voltage,medium-voltage and low-voltage field effect transistors reduces controlclock speed requirements.

Use of high-voltage field effect transistors to level shift up to themaximum then truncating down using medium-voltage and low-voltage fieldeffect transistors suggests the use of a non-overlapping clock at thehighest voltage, and to maintain synchronous timing through the network.However, using a non-overlapping clock at each stage also minimizesthrough-current and switched capacitance.

FIG. 6B is a simplified equivalent circuit diagram illustratinggeneration of different voltages by voltage multiplier 311. SwitchesSW1-SW7 switch the three capacitors C1-C3, to charge one or more of thecapacitors in charge mode and to output a desired voltage in pump mode.Switch SW1 switches a lower terminal of capacitor C1 between either thebattery voltage V_(BATT) or the ground voltage GND. Switch SW2 connectsthe upper terminal of capacitor C2 (and, depending on the state ofswitch SW3, possibly also the lower terminal of capacitor C3) to eitherthe battery voltage V_(BATT) or the output voltage terminal V_(MULT).

Switch SW3 connects the lower terminal of capacitor C3 to either thebattery voltage V_(BATT), the ground voltage GND, the upper terminal ofcapacitor C1 (and, depending on the state of switch SW5, possibly alsothe doubled battery voltage output terminal 2 V_(BATT)), or the upperterminal of capacitor C2. Switch SW4 connects the upper terminal ofcapacitor C3 to either the battery voltage V_(BATT), the output voltageterminal V_(MULT), or the doubled battery voltage output terminal 2V_(BATT).

Switch SW5 connects the upper terminal of capacitor C1 (and, dependingon the states of switches SW3 and SW6, possibly also the lower terminalsof capacitors C2 and/or C3) to either the battery voltage V_(BATT) or tothe doubled battery voltage output terminal 2 V_(BATT). Switch SW6connects the lower terminal of capacitor C2 to either the batteryvoltage V_(BATT), the ground voltage GND, or the upper terminal ofcapacitor C1. Switch SW7 selectively connects the output voltageterminal V_(MULT) to the doubled battery voltage output terminal 2V_(BATT).

In accordance with the known art, switches SW1-SW7 are controlled forcharge doubling. For instance, the voltage 2 V_(BATT) may be generatedby connecting the lower terminal of capacitor C1 to the ground voltageGND and the upper terminal of capacitor C1 to the batter voltageV_(BATT) during charge mode, then connecting the lower terminal ofcapacitor C1 to the battery voltage V_(BATT) and the upper terminal ofcapacitor C1 to the doubled battery voltage output terminal 2 V_(BATT)in pump mode. Similarly, charging capacitors C1-C3 to the batteryvoltage V_(BATT) in charge mode, then connecting the capacitors C1-C3 inseries, with the lower terminal of capacitor C1 connected to the batteryvoltage V_(BATT) and the upper terminal of capacitor C3 to the outputvoltage terminal V_(MULT) to produce the voltage 4 V_(BATT) at theoutput voltage terminal V_(MULT).

In addition, voltage multiplier 311 of the illustrated embodiment of thepresent invention is also capable of producing half-step increments forthe output voltage. For instance, capacitors C2-C3 may be connected inseries and jointly charged to the battery voltage V_(BATT) in chargemode, then connected at the common point (the upper terminal ofcapacitor C2 and the lower terminal of capacitor C3) to the outputvoltage terminal V_(MULT) to produce the voltage ½ V_(BATT). While notimplemented by the exemplary embodiment of voltage multiplier 311, theprinciple described above for generating half-step increments of thebattery voltage V_(BATT) could be readily extended to efficientlygenerate other fractional multiples of the battery voltage (e.g., ⅓V_(BATT), ¼ V_(BATT), ⅔ V_(BATT), ¾ V_(BATT), etc.).

Constant Current Voltage Limited Operation

In delivery of constant current electrical stimulation pulses, theoutput of universal custom output driver 206 is optionally voltagelimited in the present invention (implemented as a programmable mode).FIG. 7 is a circuit diagram for a constant current voltage limited pulsegenerator circuit within an output driver for an implantable pulsegenerator according to one embodiment of the present invention. Thevoltage-limiting portion of output driver 206 of the illustratedembodiment employs the digital-to-analog converter 301 and the voltagemultiplier 311. The clock signal driving voltage multiplier 311 isgenerated by a clock divider 701 operating on a reference clock signal,such as a 40 kiloHertz (KHz) local oscillator signal.

A comparator 702 compares a voltage-divided value of the output ofvoltage multiplier 311 to the output of digital-to-analog converter 301.As long as the voltage-divided output of voltage multiplier 311 is lessthan the output of digital-to-analog converter 301, the clock divider701 is allowed to run, causing the voltage multiplier to produce morevoltage. Once the voltage-divided output of voltage multiplier 311reaches the output of digital-to-analog converter, however, the clockdivider 701 is stopped, causing voltage multiplier 311 to stop producingadditional voltage and holding the existing voltage until delivery of acurrent pulse attenuates that voltage. When the voltage-divided outputof voltage multiplier 311 again drops below the output ofdigital-to-analog converter 301, the clock divider 701 is restarted,together with production of additional voltage by voltage multiplier311.

Voltage limited operation of constant current pulse delivery by theoutput driver 206 provides increased safety. If a jump in the resistanceof the current sink path occurs (e.g., the patient moves, significantlyincreasing the resistance between the anode and cathode electrodesselected from electrodes 106-113), the amplitude of the voltagedelivered could spike. Limiting the voltage used to drive the currentpulse prevents an unsafe jump in the amplitude of the voltage across theelectrodes 106-113.

In addition, because the voltage multiplier 311 is not operatedcontinuously, the power consumed by output driver 206 is reduced. Thus,while not helpful for heavy load conditions or high duty cycle and/orfast pulse conditions, constant current voltage limited operation may beemployed with less power being consumed and greater patient safetyprovided.

Although the present invention and its advantages have been described indetail, it should be understood that various changes, substitutions andalterations can be made herein without departing from the spirit andscope of the invention as defined by the appended claims. Moreover, thescope of the present application is not intended to be limited to theparticular embodiments of the process, machine, manufacture, compositionof matter, means, methods and steps described in the specification. Asone of ordinary skill in the art will readily appreciate from thedisclosure of the present invention, processes, machines, manufacture,compositions of matter, means, methods, or steps, presently existing orlater to be developed that perform substantially the same function orachieve substantially the same result as the corresponding embodimentsdescribed herein may be utilized according to the present invention.Accordingly, the appended claims are intended to include within theirscope such processes, machines, manufacture, compositions of matter,means, methods, or steps.

1. An implantable pulse generator for generating electrical pulses forstimulation of tissue of a patient, the implantable pulse generatorcomprising: a controller; pulse generating circuitry for generatingelectrical pulses, the pulse generating circuitry comprising (i) avoltage multiplier for providing a plurality of voltages for pulsegeneration and (ii) at least one variable resistance circuit disposed ina circuit path of the pulse generating circuitry to control a magnitudeof a respective electrical pulse; switching circuitry for deliveringelectrical pulses from the pulse generating circuitry to outputs of theimplantable pulse generator; and output capacitors disposed between theswitching circuitry and the outputs of the implantable pulse generator;the controller, controlling the pulse generating circuitry and theswitching circuitry, to repeatedly generate consecutive first and secondpulses to stimulate tissue of a patient using each first pulse and todischarge residual charge left on one or more output capacitors by eachfirst pulse with each second pulse, wherein the controller controls thevoltage multiplier to provide a lower voltage and controls the at leastone variable resistance circuit to provide a lower resistance for eachsecond pulse relative to each first pulse.
 2. The implantable pulsegenerator of claim 1 wherein the at least one variable resistancecircuit is a digitally controlled resistance circuit.
 3. The implantablepulse generator of claim 1 wherein the voltage multiplier outputsvoltages that include non-integer multiples of a battery voltage of theimplantable pulse generator.
 4. The implantable pulse generator of claim1 wherein the voltage multiplier comprises a plurality of outputsincluding at least one constant voltage output and at least one variablevoltage output.
 5. The implantable pulse generator of claim 4 whereinthe voltage multiplier outputs non-integer multiples of a batteryvoltage of the implantable pulse generator on the at least one variablevoltage output.
 6. The implantable pulse generator of claim 1 wherein aduration of the second pulse is longer than a duration of the firstpulse.
 7. The implantable pulse generator of claim 1 wherein the voltagemultiplier is operable to maintain charge on all storage capacitors ofthe voltage multiplier when changing an output voltage of the voltagemultiplier between the first and second pulses.
 8. A method of operatingan implantable pulse generator to generate electrical pulses forstimulation of tissue of a patient, the method comprising: operatingpulse generating circuitry to repeatedly generate first and secondelectrical pulses, the pulse generating circuitry comprising (i) avoltage multiplier for providing a plurality of voltages for pulsegeneration and (ii) at least one variable resistance circuit disposed ina circuit path of the pulse generating circuitry to control a magnitudeof a respective electrical pulse; operating switching circuitry fordelivering the first and second electrical pulses from the pulsegenerating circuitry to outputs of the implantable pulse generator,wherein output capacitors are disposed between the switching circuitryand the outputs of the implantable pulse generator; and controlling thepulse generating circuitry and the switching circuitry to stimulatetissue of the patient with each first pulse and to discharge residualcharge left on one or more output capacitors by each first pulse witheach second pulse, wherein the controlling controls the voltagemultiplier to provide a lower voltage and controls the at least onevariable resistance circuit to provide a lower resistance for eachsecond pulse relative to each first pulse.
 9. The method of claim 8wherein the at least one variable resistance circuit is a digitallycontrolled resistance circuit.
 10. The method of claim 8 wherein thevoltage multiplier outputs voltages that include non-integer multiplesof a battery voltage of the implantable pulse generator.
 11. The methodof claim 8 wherein the voltage multiplier comprises a plurality ofoutputs including at least one constant voltage output and at least onevariable voltage output.
 12. The method of claim 11 wherein the voltagemultiplier outputs non-integer multiples of a battery voltage of theimplantable pulse generator on the at least one variable voltage output.13. The method of claim 8 wherein a duration of the second pulse islonger than a duration of the first pulse.
 14. The method of claim 8wherein the voltage multiplier is operable to maintain charge on allstorage capacitors of the voltage multiplier when changing an outputvoltage of the voltage multiplier between the first and second pulses.